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ECT Citizen Petition Citizen Petition Submitted August 24, 2016 Petitioners Atze Akkerman, Evelyn Scogin, Dianna Loper Posthauer, Kenneth Fleischman and Tony Buonfiglio, hereby submit this Citizen Petition under 21 U.S.C. §§ 360e(b) and 360f(a) and 21 C.F.R. § 10.30, to request that the Commissioner of the Food and Drug Administration (“Commissioner”) either promulgate a final regulation making electroconvulsive therapy (“ECT”) devices banned devices or maintain the Class III classification of the devices and issue a final order establishing the effective date for premarket approval (PMA) for all ECT devices. Petitioner Atze Akkerman was given a round of 10 shock therapy treatments in 2003. He experienced dramatic memory loss and amnesia for his historical memory, including all memories of his children, his parents and his wife. Although he was a professional musician and toured with the Navy Band, he lost his ability to play music. He continues to suffer substantial long term memory loss and short term memory loss making learning new matters difficult. He remains on full disability following his ECT. The details of his injuries were submitted to the FDA through detailed Comment and submission of his attorney in FDA-2010-N-0585 and FDA 2014-N-1210. Mr. Akkerman also submitted a report to the MAUDE database. Mr. Akkerman is resident of California. Petitioner Evelyn Scogin is a resident of Texas who has suffered personal injury by way of persistent and continuing memory loss and cognitive damages from the receipt of ECT in 2005. She experienced dramatic memory loss, wiping out, for example, knowledge of friends and family. She has lost years of memory of her youth, as well as most of the two years of memory prior to the shock treatment. The shock damaged her ability to walk, resulting in the necessity of using a wheelchair for a considerable time. She lost several teeth broken during the procedure and suffered massive pain throughout her body. She has advocated for the abolition of ECT on children and adults, and has publicly spoken on the issue of harms arising from ECT. Ms. Scogin submitted a written statement which was read on the record to the FDA Advisory Committee in January 2011, opposing reclassification of ECT to Class II. Petitioner Dianna Loper Posthauer suffered considerable damage from the involuntary receipt of ECT over 35 years ago following post-partum depression. She thereafter didn’t know her child, didn’t remember being married, or even bearing her child. The ECT lowered her IQ and she has suffered permanent cognitive impairment, long term memory loss and new memory disability. Such damages are a continuing problem and injury. She views shock treatment as a crime against an individual’s spirit and a rape of the soul. Ms. Posthauer has advocated before government bodies and the press that ECT should be banned or sharply restricted. She submitted Comments to dockets FDA-2010-N-0585 and FDA 2014-N-1210. Ms. Postauer is a resident of Texas, and the Founder of Christians United for the Ban of Electroshock. Petitioner Kenneth (Kenny) Fleischman is a 28-year-old young man who was given 30 rounds of ECT in 2009 and 2010 at age 21. Previously a high school honor student, Kenny had to 1 relearn to tie his shoes following treatment. Kenny grew up in a difficult family situation and had normal life struggles and feelings of depression. At age 14 he was diagnosed with hypothyroidism. One of the symptoms of hypothyroidism is feelings of depression. The doctor put him on a thyroid medication and an antidepressant to “boost” the effects of the thyroid med. The antidepressant caused a worsening of his symptoms. The psychiatrist then added another drug which gave him new and worse symptoms. This pattern of adding and changing drugs continued until, at one point, he was on a cocktail of six different psychiatric drugs. He was thereafter told he was “treatment resistant” and required electroshock therapy. The risks were downplayed. Kenny was told he might have a slight memory problem, but it would come back after a few months. However, Kenny lost all memories of childhood and all memories of high school. He reports that he has lost memories of his life and who he was. Neurocognitive testing by a neurologist, done six months after the shocks, showed a loss of 50 IQ points compared to his high school IQ. Kenny suffered severe headaches for a year and a half after the shocks and was under the treatment of a cardiologist because ECT left him with heart arrhythmia. Kenny also suffered eye injury, with his eyes not tracking correctly since the shocks (Nystagmus). Kenny is on disability and unable to work. He is a resident of Michigan. Petitioner Tony Buonfiglio received a series of ECT treatments at the age of 16, several decades ago. Afterwards he was put into a special education class because his memory and cognitive abilities were so diminished. He experienced extensive and permanent memory loss, losing the memories of most of his childhood and high school. These memories have never returned. His working memory, or short term memory is very poor, making work a challenge, and is easily thrown off a train of thought. Mr. Buonfiglio is a resident of Florida. ACTION REQUESTED Petitioners respectfully request that the Food and Drug Administration (“FDA”) either: Promulgate a final regulation banning ECT devices; or Issue a final administrative order: (1) maintaining Class III designation, and requiring a premarket approval application (“PMA”) for any ECT device that is a preamendment device or any ECT device that has been found to be substantially equivalent to such a device; and (2) specifying that all other ECT devices have an approved PMA in effect before being placed in commercial distribution for any purpose. STATEMENT OF GROUNDS I. FACTUAL BACKGROUND AND REGULATORY HISTORY OF ECT DEVICES A. The FDA Initially Proposed Classifying ECT Devices into Class II The Medical Device Amendments of 1976 (“Amendments”), enacted on May 28, 1976, established three classes of medical devices: Class I (General Controls), Class II (Performance Standards), and Class III (Premarket Approval). Whether a device is Class I, II, or III depends 2 upon its intended use, indications for use, and risk to the user. An ECT device is “a device used for treating severe psychiatric disturbances (e.g., severe depression) by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.” 21 C.F.R. § 882.5940(a). Some ECT devices were marketed in the U.S. before enactment of the Amendments (hereinafter referred to as “preamendments devices”). Thus, following the Amendments, the FDA needed to classify them. Pursuant to the Amendments, in 1978, the FDA issued a proposed rule classifying ECT devices into Class II. See 43 Fed. Reg. 55729 (Nov. 28, 1978). B. The FDA Ultimately Classified ECT Devices into Class III Although the FDA initially proposed classifying ECT devices into Class II, it ultimately promulgated a final rule classifying them as Class III in response to comments it received on the 1978 proposed rule. See 44 Fed. Reg. 51776 (Sept. 4, 1979); 21 C.F.R. § 882.5940. Such comments included, inter alia, those from patients who suffered memory loss after receiving ECT treatment and wanted strict controls over the application of ECT as a result. Id. A separate comment said that the information necessary to develop a performance standard was insufficient. See id. One comment noted that ECT is inherently brain damaging and stated that the FDA could not assure effectiveness because there was no consensus regarding the effectiveness of ECT. See id. The FDA considered comments on the proposed rule at a meeting of its Neurological Section of the Respiratory and Nervous System Devices Panel. 1 A representative of the American Psychiatric Association (“APA”) told the panel that, at the request of the FDA, it formed a committee to develop standards for ECT devices and was in the process of reviewing the literature and gathering information, and that it expected to have sufficient information to write the standard in six months. Because such information did not yet exist to develop a performance standard, the panel recommended classifying ECT devices into Class III. The FDA followed the section’s recommendation. When classifying ECT devices as Class III, it stated: FDA has carefully considered the classification of electroconvulsive therapy devices and has decided to classify the devices in class III rather than class II as proposed. FDA is aware of and encourages the work of the APA committee in developing a performance standard. The agency is persuaded, however, based on the comments received on the proposal and on the recommendation of the Panel, that there is insufficient information to establish a standard to provide reasonable assurance of the safety and effectiveness of the ECT device. Id. C. The FDA Did Not Require Premarket Approval for Class III ECT Devices 1 The panel used to be called the Neurological Device Classification Panel. 3 Manufacturers of Class III devices are ordinarily required to submit a premarket approval application (“PMA”) to the FDA that contains safety and effectiveness information, including information from clinical trials. ECT devices legally marketed in the U.S. before the enactment date of the Amendments (hereinafter referred to as “preamendments devices”) or marketed after May 28, 1976, but deemed substantially equivalent to a preamendments device, do not require a PMA. The latter require a notification to the FDA under section 510(k) of the FDCA, however. Specifically, the FDA’s regulations provide: Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval..
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